Risk Management Plans (RMPs)

A risk management plan (RMP) is a document that describes the current knowledge about the safety and efficacy of a medicinal product. The RMP provides key information on plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine. It also describes measures to be undertaken to prevent or minimise risks associated with the use of the product in patients. Marketing authorisation holders are required to have an RMP for any new medicinal product for human use, which must be submitted at the time of application for marketing authorisation. For nationally authorised products, RMPs must be submitted to the HPRA for review and approval.

The format and content of the RMP should follow the requirements set out in Commission Implementing Regulation on the performance of pharmacovigilance activities provided for in regulation (EC) No 726/2004 and Directive 2001/83/EC of the European Parliament and of the Council. Further information on submission of RMPs is available on the EMA website and in Module V of the Guideline on Good Pharmacovigilance Practices.

The European Medicines Agency (EMA) and national competent authorities have adopted a risk-based approach to RMP updates. An updated RMP should be submitted by way of variation:

• At the request of the EMA, HPRA other national competent authority;

• Whenever the RMP is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile of a medicinal product or as a result of an important pharmacovigilance or risk minimisation milestone being reached.

Risk Minimisation Measures

Risk minimisation tools are used to enhance the benefit/risk balance of a medicinal product. They do this by preventing or reducing the occurrence of adverse reactions associated with the medicinal product or reducing the severity of reactions that do occur.

Risk minimisation measures are outlined in the risk management plan for a particular product. While routine risk minimisation measures apply to every medicinal product (SmPC, package leaflet, labelling, pack size(s) and legal status of the product), when considered essential for the safe and effective use of a medicinal product, additional risk minimisation measures may be required. Examples include educational materials, pregnancy prevention programmes, controlled access programmes, controlled distribution programmes and Direct Healthcare Professional Communications (DHPCs). The EMA provides guidance on risk minimisation measures in their Good Pharmacovigilance Practices in Module V – Risk management systems and also in Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators. Further information on safety communications can be found in GVP Module XV – Safety communication.

Risk minimisation measures that are a regulatory requirement must be assessed at national level by the HPRA for approval prior to their distribution and/or implementation in Ireland.

Further guidance for marketing authorisation holders on the submission of educational materials and DHPCs to the HPRA is available in the HPRA Guide to Submission of Educational Tools and Materials and the HPRA Guide on DHPCs respectively.

For DHPCs, a specific HPRA identifier should be included at the top of the first page to highlight that it contains important safety information approved by the HPRA and to distinguish the DHPC from other communications received by healthcare professionals. The identifier is available to download below.

Download the HPRA identifier 

The identifier is available to download in JPG, EPS and PDF formats using the links below. The identifier should be used in full without any modifications.

JPG

EPS

PDF